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Study Title and Description

Randomized trial of a comparison of rehabilitation or drug therapy for urgency urinary incontinence: 1-year follow-up.



Key Questions Addressed
1 KQ 1: What are the benefits and harms of nonpharmacological treatments of UI in women, and how do they compare with each other? KQ 2: What are the benefits and harms of pharmacological treatments of UI in women, and how do they compare with each other? KQ 3: What are the comparative benefits and harms of nonpharmacological versus pharmacological treatments of UI in women? KQ 4: What are the benefits and harms of combined nonpharmacological and pharmacological treatment of UI in women?
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Primary Publication Information
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TitleData
Title Randomized trial of a comparison of rehabilitation or drug therapy for urgency urinary incontinence: 1-year follow-up.
Author Kafri R., Deutscher D., Shames J., Golombp J., Melzer I.
Country Department of Physical Therapy, Schwartz Movement Analysis & Rehabilitation Laboratory, Physical Therapy Department, Recanati School for Community Health Professions, Faculty of Health Science, Ben-Gurion University of Negev, PO Box 653, Beer-Sheva 84105, Israel.
Year 2013
Numbers Pubmed ID: 23160873

Secondary Publication Information
UI Title Author Country Year
Outcomes of different protocols of pelvic floor physical therapy and anti-cholinergics in women with wet over-active bladder: A 4-year follow-up. Azuri J., Kafri R., Ziv-Baran T., Stav K. Maccabi Healthcare Services, Sackler Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel. 2017
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Extraction Form: All studies
Arms
Number Title Description Comments
1 Tolterodine
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2 Bladder training
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3 Pelvic floor muscle training
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4 Combined pelvic floor rehabilitation
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Design Details
Question... Follow Up Answer Follow-up Answer
Study type RCT
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Country/countries Israel
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Funding source Explicitly not industry funded
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Inclusion criteria women, aged 45-75, experienced at least 3 episodes of UUI/week over the past 4 weeks; PFM contraction Oxford strength scale >=2, no vaginal prolapse; residual urine volume < 100 ml
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Exclusion criteria current UTI, neurological disease, psychiatric or depressive disorder, previous pelvic floor surgery or physical therapy
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UI type 100
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episodes of UUI not completely explained by SUI symptoms
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Age 56.7
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mean
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8.0
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Men included 0
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Special populations
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100
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Race
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100
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Notes
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Did participants fail previous treatment? Not reported/unclear
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Study years nd
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Trial name (if given)
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Does this paper cite a previous paper from the same study? yes; all are in publications tab
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Baseline Characteristics
Question Tolterodine Bladder training Pelvic floor muscle training Combined pelvic floor rehabilitation Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 42 41 40 41 164
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27 39 32 37 135
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15 2 6 4 29
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no respons (13), acute back pain (1), dizziness (1) medical condition (1) no response (1) nd no response (4) see above
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Notes No data entered.



Results & Comparisons


Results Data
Outcome: Quality of life      Population: All Participants
Time Point Measure Tolterodine Bladder training Pelvic floor muscle training Combined pelvic floor rehabilitation


1 years

N Analyzed
Counts
Outcome: Cure etc.      Population: All Participants
Time Point Measure Tolterodine Bladder training Pelvic floor muscle training Combined pelvic floor rehabilitation


4 years

N Analyzed 24 35 29 30
Counts 6 11 13 11
Net P value
Outcome: Incontinence count/frequency (urgency)      Population: All Participants Between-Arm Comparisons
Time Point Measure Tolterodine Bladder training Pelvic floor muscle training Combined pelvic floor rehabilitation Comparison Measure All Arms (ANOVA)


0 years

N Analyzed 42 41 40 41
Mean 9.2 5.7 6.3 6.5
SD 11.9 6.1 7.9 7.5
SE
Median
note baseline much higher in this arm than in any other arm


1 years

N Analyzed 27 39 32 37 0.503
Mean 5.2 2.8 3.0 3.0
SD 11.4 3.9 6.2 4.7
SE
Net P value Net P value
Outcome: Bladder control, subjective      Population: All Participants Between-Arm Comparisons
Time Point Measure Tolterodine Bladder training Pelvic floor muscle training Combined pelvic floor rehabilitation Comparison Measure All Arms (ANOVA)


0 years

N Analyzed 42 41 40 41
Mean 7.2 7.3 6.7 7.2
SD 2.0 2.0 2.5 2.6
SE
Median


1 years

N Analyzed 27 39 32 37 0.289
Mean 4.0 4.3 4.1 3.3
SD 3.1 3.3 3.3 2.9
SE
Median
Net P value Net P value
Outcome: Other UI measure (placeholder)      Population: All Participants Between-Arm Comparisons
Time Point Measure Tolterodine Bladder training Pelvic floor muscle training Combined pelvic floor rehabilitation Comparison Measure All Arms (ANOVA)


0 years

N Analyzed 42 41 40 41
Mean 2.0 2.5 2.7 2.7
SD 1.9 2.0 1.8 1.5
SE
Median


1 years

N Analyzed 27 39 32 37 0.318
Mean 1.7 1.7 2.2 2.1
SD 1.4 1.6 1.8 1.5
SE
Median
Net P value Net P value
Outcome: Leakage test: Pad test      Population: All Participants Between-Arm Comparisons
Time Point Measure Tolterodine Bladder training Pelvic floor muscle training Combined pelvic floor rehabilitation Comparison Measure All Arms (ANOVA)


0 years

N Analyzed 42 41 40 41
Mean 17.7 12.4 17.8 13.7
SD 16.0 11.1 31.6 13.6
SE
Median


1 years

N Analyzed 27 39 32 37 0.939
Mean 13.2 9.9 13.2 8.3
SD 13.1 11.1 31.7 8.3
SE
Median
Outcome: Incontinence Severity Index      Population: All Participants
Time Point Measure Tolterodine Bladder training Pelvic floor muscle training Combined pelvic floor rehabilitation


0 years

N Analyzed 42 41 40 41
Mean 6.5 6.7 5.4 6.4
SD 3.5 3.3 3.6 3.3
SE
Median


1 years

N Analyzed 27 39 32 37
Mean 4.1 4.3 2.9 3.9
SD 3.0 3.8 3.0 3.4
SE
Median


Quality Dimensions
Dimension Value Notes Comments
RCT:.....Adequate generation of a randomized sequence Low RoB
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RCT:.....Allocation concealment Low RoB
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RCT:.....Blinding of PATIENTS High RoB Patients we not blinded
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RCT.....Intention-to-treat-analysis Low RoB
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ALL.....Blinding of OUTCOME ASSESSORS (or "DOUBLE BLIND") Low RoB
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ALL.....Incomplete results data (attrition bias) High RoB much higher dropout rate in the drug arm than any other (36%)
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ALL....Group similarity at baseline (selection bias) Low RoB
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ALL.....Compliance with interventions High RoB adherence to drug = 64%; others 85-95%
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NRCS.....Patients in different intervention groups selected in an equivalent manner
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NRCS....Baseline differences between groups accounted for (Adjusted analysis)?
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ALL.....Other issues
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ALL....Were interventions adequately described? Yes
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Quality Rating
No quality rating data was found.